MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 6.6F DIGNITY LP CT PORT; DIGNITY CT-PORT

Model Number	MRDP66PLS
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the sterilization certificates for the loads the lots were processed on indicated that the loads passed all requirements of sterilization.There were no non-conformances during the sterilization process.Sterilization of medcomp product is performed according to iso standard 11135 "medical devices- validation and routine control of ethylene oxide sterilization".Infections are the most common complication after implantation of a venous port system.Infections of port venous systems include pocket and/or tunnel cellulitis or the more common catheter-related blood stream infections.Instructions for use contain the following potential complication- catheter or port related sepsis.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The facility submitted a voluntary event report stating there were three bloodstream infections in oncology patients with port over 18 day period.No other information was provided.

• Brand Name: 6.6F DIGNITY LP CT PORT
• Common Device Name: DIGNITY CT-PORT
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 11723627
• Report Number: 2518902-2021-00023
• Device Sequence Number: 3894625
• Product Code: LJT
• UDI-Device Identifier: 00884908149890
• UDI-Public: 884908149890
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: MRDP66PLS
• Device Catalogue Number: MRDP66PLS
• Device Lot Number: MNXJ480, MPFN020
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1